Events

Retiro De Equipo (Recall) de ViewPoint 6 Versions 6.2, 6.2.1, 6.3 and 6.31 including OB Pro-Expert Reporting (Ultrasound image management software)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00812-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-02
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00812-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Ge healthcare has become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (piv) for venous flow measurements. the ductus venous piv measurement can be incorporated into the first trimester risk assessment for chromosomal abnormalities. in case of negative flow patterns, the viewpoint calculated doppler piv for veins could be incorrect, leading to a false high risk for trisomy 13, 18, and 21.
  • Acción
    GE Healthcare is advising users to discontinue use of venous PIV for making any clinical decisions, in particular, discontinue use of the ductus venous PIV for first trimester risk assessment. GE Healthcare will be providing a software upgrade as a permanent fix.

Device

ViewPoint 6 Versions 6.2, 6.2.1, 6.3 and 6.31 including OB Pro-Expert Reporting (Ultrasound image...
  • Modelo / Serial
    ViewPoint 6 Versions 6.2, 6.2.1, 6.3 and 6.31 including OB Pro-Expert Reporting (Ultrasound image management software)ARTG Number: 178864
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd